Page last updated: October 4, 2003
WHAT
The start of new Food and Drug Administration requirements
for laboratories using analyte specific reagents (ASRs). ASRs are reagents
composed of chemicals or antibodies that may be thought of as the "active
ingredients" of in-house developed tests and purchased from manufacturers
under this label.
The FDA defines ASRs as "antibodies, both polyclonal
and monoclonal, specific receptor proteins, ligands, nucleic acid sequences,
and similar reagents which, through specific binding or chemical reaction
with substances in a specimen, are intended for use in a diagnostic application
for identification and quantification of an individual chemical substance
or ligand in biological specimens."
The majority of ASRs are exempt from FDA approval or
clearance.
Manufacturers of ASRs are prohibited from making claims
of analytical or clinical performance.
The FDA very clearly distinguishes ASRs from immunohistochemistry
(IHC) reagents (final rule effective Aug. 17, 1998). The FDA defines IHCs
as "in vitro diagnostic devices...intended to identify, by immunological
techniques, antigens in tissue or cytologic specimens." Unlike ASRs, IHCs
are labeled by manufacturers with directions for use and performance indications.
WHEN
Beginning November 23, 1998.
WHO
Laboratories using ASRs are required to include a disclaimer
on test reports that reads: "This test was developed and its performance
characteristics determined by (laboratory name). It has not been cleared
or approved by the U.S. Food and Drug Administration."
The College recommends, and the FDA has agreed to,
the use of additional clarifying report language by laboratories stating
that ASR use does not require FDA approval.
Promotional and advertising materials for ASRs shall
include the statement: "Analyte Specific Reagent. Analytical and performance
characteristics are not established." Also, claims cannot be made regarding
analytical or clinical performance.
Laboratories using products labeled by manufactures
as IHC reagents are not required to use a disclaimer statement.
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